Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness

NCT07441083 | Recruiting

• 1 other identifier: Ixo/2025/1314/SHT/SexWel/GB/01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, placebo-controlled clinical study is designed to evaluate the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) in improving women's sexual wellness. Sexual wellness is assessed as a multidimensional construct encompassing sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers. Participants will receive either Shatavari root extract or placebo for 12 weeks, with assessments conducted at baseline and follow-up visits.

Conditions

Sexual Wellness; Women Health

Keywords

dietary supplement; shatavari

Outcome Measures

Primary Outcomes (1)

• Change in Female Sexual Function Index (FSFI) total score

  The Female Sexual Function Index (FSFI) is a validated 19-item self-reported questionnaire assessing female sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2.0 to 36.0, with higher scores indicating better sexual function (better outcome). This outcome measures the mean change from baseline in FSFI total score, where an increase in score indicates improvement in female sexual function.

  Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (11)

• Change in Female Sexual Distress Scale (FSDS) Score

  Baseline, Week 4, Week 8, Week 12

• Change in Global Measure of Sexual Satisfaction (GMSEX) Score

  Baseline, Week 4, Week 8, Week 12

• Change in Perceived Stress Scale (PSS-10) Score

  Baseline, Week 4, Week 8, Week 12

• Change in PROMIS-29 Quality-of-Life Scores

  Baseline, Week 4, Week 8, Week 12

• Change in Salivary Cortisol Awakening Response (CAR)

  Baseline and Week 12

Study Arms (2)

Shatavari Root Extract (SRI-81) 300 mg

EXPERIMENTAL

Participants randomized to this arm will receive a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) capsule containing 300 mg, administered orally once daily after breakfast with water for a duration of 12 weeks. The intervention is intended to evaluate the efficacy and safety of Shatavari root extract in improving women's sexual wellness, including sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers, compared with placebo.

Dietary Supplement: Shatavari (Asparagus racemosus) Root Extract

Placebo Capsule (Starch) 300 mg

PLACEBO COMPARATOR

Participants randomized to this arm will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks. The placebo is matched in appearance, color, and packaging to the active intervention to maintain blinding. This arm serves as the comparator for evaluating the efficacy and safety of Shatavari root extract in women's sexual wellness.

Other: Placebo Capsule

Interventions

Shatavari (Asparagus racemosus) Root Extract DIETARY_SUPPLEMENT

The investigational intervention is a standardized Shatavari (Asparagus racemosus Willd.) root extract (SRI-81), manufactured under current Good Manufacturing Practice (cGMP) conditions. Each capsule contains 300 mg of Shatavari root extract with an herb-to-extract ratio of 13:1 and is standardized to contain ≥10% total Shatavarins, quantified by high-performance liquid chromatography (HPLC). Participants will self-administer one capsule orally once daily after breakfast with water for 12 weeks. The product is designed to support stress modulation and neuroendocrine balance, which may contribute to improvements in women's sexual wellness outcomes.

Also known as: Asparagus racemosus root extract

Shatavari Root Extract (SRI-81) 300 mg

Placebo Capsule OTHER

The placebo intervention consists of an orally administered capsule containing 300 mg of inert starch. The placebo capsules are identical in size, color, appearance, and packaging to the active Shatavari intervention to ensure double blinding of participants and study personnel. Participants will self-administer one capsule once daily after breakfast with water for 12 weeks. The placebo contains no active herbal or pharmacological ingredients and is used solely for comparison with the investigational Shatavari root extract.

Also known as: Starch Capsule

Placebo Capsule (Starch) 300 mg

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 20 to 50 years of age.
• Sexually active, attempting sexual activity, or experiencing concerns related to sexual desire or function, with a partner and have a FSFI total score ≤ 26.55.
• Have a PSS-10 score of ≥ 14 at screening.
• Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
• Participants who are reliable, honest, compliant, and agree to co operate with all trial evaluations as well as to be able to perform them as per investigator's opinion.
• Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
• Able to read and write in English or any other vernacular language.
• No plan to commence new treatments over the study period.
• Must have the ability and willingness to sign a written informed consent and to comply with all study procedures.

You may not qualify if:

• Participants taking any form of herbal extract in the last 3 months before study entry.
• Participants with hormonal imbalance including PCOS, and symptoms of perimenopause and menopause
• Participants who are on hormone replacement therapy (HRT) for more than 3 months.
• Participants with any active medical, surgical, or gynaecological problems.
• Participants with a history of alcohol, tobacco dependence, or any other substance abuse
• Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult.
• Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Participants with demonstrated inability to comply with the study procedures, including poor compliance.
• Participants with inability to attend follow-up visits.
• Patients with known hypersensitivity to Shatavari, or any of the ingredients of study interventions.
• Patients who had participated in other clinical trials during the previous 3 months.
• Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.

Sponsors & Collaborators

• SF Research Institute, Inc.: lead
• Ixoreal Biomed Private Limited: collaborator

Study Sites (1)

San Francisco Research Institute

San Francisco, California, 94132, United States

RECRUITING

MeSH Terms

Interventions

Starch

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Central Study Contacts

Dr. John Ademola

CONTACT

415-845-4638; jademola@sfinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)